Efficacy of Pediatric Rotary File System Versus Hand Instrumentation for Root Canal Preparation in Primary Teeth: An In Vivo and In Vitro Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Sensitivity to percussion
研究概览
简要总结
The teeth were randomly allocated in two equal groups :
Control group (A):- included 20 mandibular primary molars in which pulpectomy were performed by hand instrumentation system using K- File from size 15 to size 35.
Experimental Group (B):- included 20 mandibular primary molars in which pulpectomy were performed by rotary system using Kedo-SG rotary file system according to manufacturer's instructions
Methods of Evaluation
Stage I :- During and after canal preparation:- The following parameters were evaluated for all cases in both groups:- A- The instrumentation and canal filling time were recorded for both groups using stopwatch. B- Radiographic assessment for filling were done immediately postoperative to record :-
- Distance between the apex to filling level of the mesial and distal roots .
- Obturation form
Stage II : Follow up :
The follow up were carried out by clinical and radiographic evaluation for all cases in both groups:-
The clinical evaluation were carried out at (0 base line = after 7 days ) then after 1 , 3 , 6 and 12 months .
Radiographic evaluation were performed immediately postoperative as (0 baseline ) after cementation of stainless steel crowns for assessment of filling quality. Radiographs will be used for comparison for consequent radiographs . Follow ups were performed after 6 and 12 months.
详细描述
The planned study is a randomized clinical controlled trial including apparently healthy children who were selected from the patients attending the Out- Patient Clinic , Pediatric Dentistry Department, Faculty of Dentistry, Suez Canal University. Informed written consent were obtained from parents or guardians of the children after full explanation of clinical procedures and detailed treatment plan.
The teeth were randomly allocated in two equal groups :
Control group (A):- included 20 mandibular primary molars in which pulpectomy were performed by hand instrumentation system using K- File from size 15 to size 35.
Experimental Group (B):- included 20 mandibular primary molars in which pulpectomy were performed by rotary system using Kedo-SG rotary file system according to manufacturer's instructions
Clinical procedures :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mandibular primary molars with deep caries indicated for pulpectomy
- •Restorable lower primary molars.
- •History of spontaneous pain or pain that is not relieved by analgesics.
- •Pain with percussion
- •Excessive bleeding from the root canals
排除标准
- •Allergy to any medications used .
- •Inability to come in recall visits . mandibular primary molars with exclusion criteria as follows:-
- •Acute or chronic abscess & fistula.
- •Inter-radicular or periapical bone destruction (radiolucency) as revealed in the preoperative periapical radiograph .
- •Mobility grade III.
- •Internal root resorption.
结局指标
主要结局
Sensitivity to percussion
时间窗: baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline
Presence (1) or Absence (0)
Radiographic examination " internal or external root resorption"
时间窗: baseline (immediately after procedure), after 6 months and 12 months from baseline
Presence (1) or absence (0)
Changes in mucobuccal folds (swelling, abscess or fistula)
时间窗: baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline
Presence (1) or Absence (0)
Spontaneous Pain
时间窗: baseline (immediately after procedure), after 7 days, after 1 month, 3 months, 6 months and 12 months from baseline
A scale from 1 to 10 where 1 is mild pain and 10 Worst pain
Radiographic examination " furcation radiolucency"
时间窗: baseline (immediately after procedure), after 6 months and 12 months from baseline
Presence (1) or absence (0)
Tooth mobility
时间窗: baseline (immediately after procedure), after 6 months and 12 months from baseline
Presence (1) or absence (0)
Radiographic evaluation " widening of apical periodontal membrane space "
时间窗: baseline (immediately after procedure), after 6 months and 12 months from baseline
Presence (1) or absence (0)
次要结局
- The instrumentation and canal filling time(immediately postoperative)
- Radiographic assessment(immediately postoperative)